Complete Guide to Cleanroom Gloves for Pharmaceutical Manufacturing

Complete Guide to Cleanroom Gloves for Pharmaceutical Manufacturing

Pharmaceutical manufacturing requires the highest standards of contamination control. Cleanroom gloves are essential protective equipment that prevents contamination of sterile products and ensures compliance with regulatory standards.

Understanding Cleanroom Classifications

Cleanrooms are classified according to ISO 14644-1 standards based on the number of particles per cubic meter:

• Class 10: Ultra-clean environment with ≤10 particles ≥0.1μm per cubic meter
• Class 100: ≤100 particles ≥0.1μm per cubic meter
• Class 1,000: ≤1,000 particles ≥0.1μm per cubic meter
• Class 10,000: ≤10,000 particles ≥0.1μm per cubic meter

Key Features of Pharmaceutical Cleanroom Gloves

Material Selection

Nitrile Gloves

• Excellent chemical resistance
• Low particle shedding
• Latex-free alternative
• Suitable for Class 10-10K environments

Latex Gloves

• Superior tactile sensitivity
• Excellent barrier properties
• Natural material with good elasticity
• Requires powder-free formulation for cleanrooms

AQL Standards

Acceptable Quality Level (AQL) determines glove quality:

• AQL 1.5: Premium quality, <1.5% defect rate
• AQL 2.5: Standard quality, <2.5% defect rate
• AQL 4.0: Basic quality, <4% defect rate

For pharmaceutical applications, AQL 1.5 is recommended.

Sterilization Methods

Gamma Sterilization

• High-energy radiation sterilization
• Penetrates packaging materials
• No residue or chemical changes
• Ideal for single-use applications

ETO Sterilization

• Ethylene oxide gas sterilization
• Effective for heat-sensitive materials
• Requires aeration period
• Suitable for complex products

Best Practices

1. Proper Donning: Follow aseptic technique
2. Regular Inspection: Check for defects before use
3. Change Frequency: Replace gloves regularly based on activity
4. Storage: Maintain in controlled environment
5. Documentation: Track lot numbers and certifications

Compliance Requirements

• ISO 13485: Quality management for medical devices
• EU GMP: Good Manufacturing Practice compliance
• FDA 21 CFR Part 820: Quality system regulations
• ISO 14644-1: Cleanroom classification standards

Choosing the Right Glove

Consider these factors:

• Cleanroom classification requirement
• Chemical compatibility
• Tactile sensitivity needs
• Duration of use
• Sterilization method compatibility
• Regulatory compliance

Conclusion

Selecting the right cleanroom gloves is critical for pharmaceutical manufacturing success. Sterimed offers premium cleanroom gloves with AQL 1.5 certification, suitable for Class 10-10K environments, with gamma and ETO sterilization options.

Sterimed Product Range

Standard Cleanroom Gloves (Meditek Brand)

• Clean Room Nitrile - Long Cuff: Class 10-10K compatible, AQL 1.5 certified
• Clean Room Nitrile - Short Cuff: Class 10-10K compatible, AQL 1.5 certified
• Clean Room Latex - Long Cuff: Class 10-10K compatible, AQL 1.5 certified
• Clean Room Latex - Short Cuff: Class 10-10K compatible, AQL 1.5 certified

Contact us to discuss your pharmaceutical cleanroom glove requirements.